MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING .IMPRESS®.BRAIDED; PERIPHERAL CATHETERS

Catalog Number	56538VER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that while performing a percutaneous nephrolithotomy procedure, the catheter tip detached within the patient's kidney.The physician had acquired non vascular access and a catheter was advanced over a glide wire into position.The glide wire was then removed with no issues to report, and an 0.035 3cm j tip stiff guidewire was advanced through the catheter.When the.035 stiff guidewire passed throughout the tip of the catheter, the catheter tip detached.The clinician successfully externalized the foreign body with a vascular snare device.The procedure was delayed but progressed after successful retrieval of the foreign body.No addition patient consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: .IMPRESS®.BRAIDED
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14713883
• Report Number: 3010665433-2022-00057
• Device Sequence Number: 20142208
• Product Code: DQO
• UDI-Device Identifier: 00884450027080
• UDI-Public: 884450027080
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2024
• Device Catalogue Number: 56538VER
• Device Lot Number: E2310094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ STIFF .035 3CM J TIP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown